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The Cricket 2000 is a recording pulse oximeter which measures functional blood oxygen saturation, pulse rate/interval and finger movement. Because of SpO2 and pulse rate alarm limits that can be sct by the operator, it can be used for continuous monitoring. It also interfaces with a commercially available computer. The pulse oximetry, raw infrared and red waveform data, as well as the pulse rate data, can be viewed real-time on the computer using custom Windows -based software that is provided with the pulse oximeter. The software also enables the user to do some data analysis, which can be used to draw meaningful implications during sleep apnca analysis studies. The Cricket 2000 is primarily indicated for use with patients suspected of suffering from, or with potential to suffer from, episodes of hypoxemia. The Cricket 2000 is intended for patients weighing more than 30 kg in both the hospital/institutional environment (supervised) and the home (unsupervised) environment.

The Cricket 2000 is a recording pulse oximeter which measures functional blood oxygen saturation, pulse rate/interval and finger movement. Because of SpO2 and pulse rate alarm limits that can be set by the opcrator, it can be used for continuous monitoring. It also interfaces with a commercially available computer. The pulse oximerry, raw infrared and red waveform data, as well as the pulse rate data, can be viewed real-time on the computer using custom Windows -based software that is provided with the pulse oximeter. The software also enables the user to do some data analysis, which can be used to draw meaningful implications during sleep apnea analysis studies.

The provided text describes a 510(k) submission for a pulse oximeter, primarily focusing on a software modification. It does not contain information about acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested.

Therefore, I cannot fulfill the request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size and data provenance for a test set.
3. Number and qualifications of experts for ground truth.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance results.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document discusses the device's intended use, general description, and lists predicate devices, but lacks the detailed performance and study information required to answer the questions. It's a regulatory document for a software modification, not a performance study report.

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